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Shimadzu and UMG Göttingen Enter Analytics Collaboration
The collaboration will see Shimadzu and UMG develop new clinical laboratory methods using LC-MS for TDM analysis.
MGI and Imperial College London Establish Overseas Customer Experience Center in the UK
MGI and Imperial College will jointly operate a CEC designed to provide European customers with first-hand experience with various automation and sequencing instruments.
Scorpion Biological Services Opens San Antonio Biologics Facility
Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.
Gerresheimer and Nelson Labs NV Announce E&L Partnership
Gerresheimer and Nelson Labs will work together to conduct extractables and leachables testing on upcoming primary packaging solutions.
Merck and Veeva Ink 10-Year Partnership Agreement
Under this deal, Merck, known as MSD outside of the United States and Canada, will select Veeva products for industry-specific software and data.
J&J to Acquire Abiomed for $16.6 Billion
Johnson & Johnson’s acquisition of Abiomed, a provider of heart pump technologies, is designed to bolster their position in the medical technology sector.
Steriline Showcases Filling Equipment at CPHI 2022
Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.
Lonza and Singzyme Enter Bioconjugates Partnership
Lonza and Singzyme will use Singzyme’s enzymatic conjugation platform to develop novel bioconjugates.
Terumo Pharmaceutical Solutions Expands CDMO Services
The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.
Purolite and Repligen Announce Ligand Partnership
Purolite and Repligen have extended their existing ligand partnership through 2032.
Ashland Injectable Pharmaceutical Excipient Accepted into FDA Novel Excipient Review Pilot Program
FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.
FDA Embroiled in Reproductive Rights Debate
A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.
FDA User Fees Reauthorized
FDA keeps its user fees but fails to gain important reforms.
Roquette Launches Next-Generation Direct Compression Solutions
Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.
Venture Capital Funding to Fuel Pharma Outsourcing
The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.
CSafe and BioLife Solutions Partnership Will Expand Supply Chain for Cell and Gene Therapies
The newly formed partnership between CSafe and BioLife will expand cold chain supply chain solutions for the cell and gene therapy market.
FDA Approves AstraZeneca’s Imjudo for Combination Liver Cancer Treatment
AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.
Pressure Mounts for FDA to Reform Accelerated Approval Program
An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.
Cambrex Announces Stability Storage Expansions in Ireland and Belgium
Cambrex has expanded its stability storage business, Q1 Scientific, in Ireland and Belgium.
WHO Ranks South Africa’s Vaccine Regulatory System at a Functional Level of Maturity
South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.
Societal CDMO Signs Multiple CDMO Service Agreements
Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.
Aragen to Invest in New Formulation Manufacturing Facility in Hyderabad, India
Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.
Recipharm to Add High-Speed Filling Line to Wasserburg Facility
Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.
AAPS to Provide Scientific Programming Oversight for Interphex
AAPS will exclusively advise RX Global on scientific focus areas for Interphex 2023, which is set to take place at the Javits Center in New York City next spring.
EMA Recommends Adapted Spikevax Vaccine
The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.
EMA Extends Use of COVID-19 Vaccines to Children
The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.
Gilead and MacroGenics Enter $1.7 Billion Oncology Collaboration
Gilead and MacroGenics will work together on bispecific antibodies for the treatment of blood cancers.
Post-Transplant Lymphoproliferative Disease Treatment Receives Marketing Authorization Recommendation from EMA
Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.
EMA Announces Positive Indication for Takeda’s Dengue Vaccine
Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.
Merck and Moderna Enter $250 Million Cancer Vaccine Partnership
Merck has exercised a $250 million option with Moderna to jointly develop and commercialize cancer vaccine mRNA-4157/V940.
